United States - English - NLM (National Library of Medicine)

remedyrepack inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine tablet is indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine tablet is indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine tablet is indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical   studies ( 14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar di

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - tolvaptan 15mg;   - tablet - 15 mg - active: tolvaptan 15mg   excipient: hyprolose indigo carmine aluminium lake lactose monohydrate magnesium stearate maize starch microcrystalline cellulose - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - tolvaptan 30mg;   - tablet - 30 mg - active: tolvaptan 30mg   excipient: hyprolose indigo carmine aluminium lake lactose monohydrate magnesium stearate maize starch microcrystalline cellulose - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios tillomed spain, s.l.u. - febuxostat - film-coated tablet - 120 milligram(s) - febuxostat

Canada - English - Health Canada

auro pharma inc - montelukast (montelukast sodium) - tablet (chewable) - 4mg - montelukast (montelukast sodium) 4mg - leukotriene modifiers

Canada - English - Health Canada

auro pharma inc - montelukast (montelukast sodium) - tablet (chewable) - 5mg - montelukast (montelukast sodium) 5mg - leukotriene modifiers

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride 37.5 mg - venlafaxine extended release tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1) ]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. venlafaxine extended release tablets are indicated for the treatment of social an